Events

Avis De Sécurité sur Plan RT and iPlan RT Dose (all versions),BrainSCAN

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par BRAINLAB AG.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-11-23
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Due to the inaccurate introduction in brainlab radiation treatment planning software, this interpolation between the measured values less accurate a) smaller when the field and b) at a larger deviation of the equivalent field size from the measured value. with some treatment settings, this results in an insufficient number of monitor units (mus) being calculated and consequently a lower dose than planned. please note that the reported dose does not exceed the intended dose due to the problem described.

Device

Plan RT and iPlan RT Dose (all versions),BrainSCAN

Manufacturer

BRAINLAB AG